Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
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Displaying 20 of 195Manuel Castellà
Background: There are no proven therapies for COVID-19 infection. COVID-19 infects the respiratory epithelium of the lower airways, causing widespread damage via cytopathic effects, resulting in severe inflammation and Pneumonitis. High local and circulating levels of cytokines, or cytokine storm, can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS). Methods: This is a pilot randomized, controlled, uni-center study testing safety and efficacy of cytokine filtration on patients with severe ARDS. Eligible patients will be randomized to 72 hours filtration or no filtration on top of the standard treatment for ARDS. Indications for randomization are patients with moderate or severe ARDS with need of ventilation support (either invasive or non-invasive), with inflammatory markers. The primary outcome will be days on mechanical ventilation (MV) support. Secondary outcomes are 30-day mortality, ICU days, need for extracorporeal membrane oxygenation (ECMO) support, duration of renal replacement therapy (RRT) and catecholamine therapies, hospital length of stay, multi-organ failure. All analysis will be done according to the intention to treat principle.
Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick
The purpose of this registry study is to investigate the effectiveness and safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of COVID-19 patients.
Fuzhou General Hospital
The outbreak of coronavirus disease 2019 (COVID-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ALI), which developed into severe respiratory distress syndrome (ARDS). The mortality was as high as 20% -40%. Due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for COVID-19 pneumonia. Its cure is essentially dependent on the patient's immunity. While the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases. Mesenchymal stem cells (MSCs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of COVID-19 pneumonia. MSCs prevent cytokine storms by retarding the TNF-α pathway, alleviate sepsis by modulating macrophages, neutrophils, NK cells, DC cells, T lymphocytes and B lymphocytes. After infused, MSCs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.
Texas Cardiac Arrhythmia Research Foundation
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
King Fahad Specialist Hospital Dammam
. Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred to as Coronavirus disease 2019 (COVID-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constraints leading to laying off labors, an increase in the unemployment rate, and major companies' bankruptcies. However, returning to normal business operations should be done with a safety focus and not be at the cost of global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for a future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions.
Semmelweis University
The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.
University Health Network, Toronto
This study proposes to compare the effectiveness of two different levels of PPE in protecting front-line health care workers from self-contamination with droplets and aerosolized particles during a simulated endotracheal intubation, an aerosol-generating medical procedure.
Erzincan University
In this study; We aimed to investigate the role of pleth variability index, which is a noninvasive method, in showing fluid response in SARS-CoV-2 (COVID-19) patients, which we know is appropriate fluid management.
Guy's and St Thomas' NHS Foundation Trust
This is a prospective observational cohort study of healthcare workers working in high-risk COVID-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and PCR Swabs. It will provide information about how many healthcare workers develop COVID-19, what their clinical observations and symptoms are.
Koc Healthcare Istanbul American Hospital, Marmara University Hospital
Covid-19 infection is an on-going pandemic with worse diagnosis in adults with comorbid conditions such as hypertension and cardiopulmonary diseases. Obstructive sleep apnea (OSA) is common in those comorbidities and may contribute to worse prognosis for the Covid-19 cases.